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临床试验/NCT03829618
NCT03829618终止3 期

Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
29
试验地点
1
主要终点
Cough

研究概览

简要总结

The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.
  • Diagnosis of pulmonary disease requiring flexible bronchoscopy
  • Greater than 18 years of age.

排除标准

  • Any intervention beyond flexible bronchoscopy and endobronchial ultrasound
  • Inability to tolerate bronchoscopy.
  • Patients that receive paralytics.
  • Patients with neuromuscular diseases.
  • Inability to consent for procedures.
  • Allergies to lidocaine or any other drugs used in protocol.
  • Existing renal insufficiency or liver disease

研究组 & 干预措施

Topical Lidocaine

Active Comparator

16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.

干预措施: Topical lidocaine (Drug)

Nebuliser Solution

Active Comparator

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.

干预措施: Nebuliser solution (Drug)

Nebuliser Suspension

Active Comparator

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.

干预措施: Nebuliser Suspension (Drug)

结局指标

主要结局

Cough

时间窗: 1 day

Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl

次要结局

  • Number of Participants With Post-Procedure Subjective Cough(1 day)
  • Anesthesia Time to Wake up(1 day)
  • Fentanyl Dosing(1 day)
  • Alfentanyl Dosing(1 day)
  • Propofol Dosing(1 day)
  • Number of Participants With Post-procedure Sore Throat(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Toth

Professor of Medicine and Surgery, Director of Interventional Pulmonology

Milton S. Hershey Medical Center

研究点 (1)

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